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Late-stage Ovarian Cancer Study Sees Failure of Novartis’ Patupilone


Novartis has announced that its late-stage study failed to show patupilone improved overall survival for patients with advanced ovarian cancer.

The Phase III study was an open label, active controlled, parallel group, multicenter trial of 829 patients with epithelial ovarian, primary fallopian or primary peritoneal cancer, who were randomized to receive patupilone or Doxil®/Caelyx® (pegylated liposomal doxirubin). The study involved approximately 168 sites in 22 countries.

Patients involved in the study had received up to a maximum of three prior chemotherapeutic regimens, of which the first was a taxane/platinum therapy, prior to enrollment in the trial and random assignment to receive intravenous patupilone (10 mg/m2) once every three weeks or Doxil®/Caelyx® (50 mg/m2) once every four weeks. Patients were evaluated for disease status by Ca-125 and CT scans every eight weeks until disease progression. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, safety and overall response rate.

No new or unexpected serious adverse events in the patupilone arm were identified in the trial, but patupilone failed to improve the overall survival of patients. Also, investigators involved in the study and regulatory agencies were notified of the trial outcome.

Patupilone, or EPO906, belongs to a class of microtubule stabilizers called epothilones and is being evaluated in ongoing trials in multiple tumor types, including metastatic colorectal cancer, brain metastases in non-small cell lung cancer or NSCLC and hormone-refractory prostate cancer or HRPC.

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Novartis does not plan to proceed with regulatory filings.

There are approximately 21,550 new cases of ovarian cancer each year in the United States, and approximately 14,600 deaths from the disease.

Symptoms of ovarian cancer include:
* Bloating
* Pelvic or abdominal pain
* Difficulty eating or feeling full quickly
* Urinary symptoms (urgency or frequency)

Women with ovarian cancer report that symptoms are persistent and represent a change from normal for their bodies. The frequency and/or number of such symptoms are key factors in the diagnosis of ovarian cancer. Several studies show that even early stage ovarian cancer can produce these symptoms.

Women who have these symptoms almost daily for more than a few weeks should see their doctor, preferably a gynecologist. Prompt medical evaluation may lead to detection at the earliest possible stage of the disease. Early stage diagnosis is associated with an improved prognosis.

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National Cancer Institute